Hypertension
Conditions
Keywords
Hypertension, Latinos, Medication Adherence, Blood Pressure Control, Patient-centered, Black
Brief summary
The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.
Detailed description
Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Interventions
BEHAVIORALAdherence Intervention
Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
OTHERAttention Control
Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
Sponsors
Merck Sharp & Dohme LLC
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have uncontrolled hypertension defined as BP\>140/90 mmHg on at least two consecutive visits in the past year (or BP\>130/80 mmHg for those with diabetes or kidney disease) and Framingham Risk Scores (FRS) \>20% (or at least one CVD risk factor including hyperlipidemia or diabetes); * Have been prescribed at least one antihypertensive or oral anti-diabetic medication; * Self-identify as Latino or African American/Black * Be \> 18 years of age
Exclusion criteria
* Refuse or are unable to provide informed consent; * Currently participate in another hypertension study; or 2 diabetes study * Have significant psychiatric comorbidity * Plan to discontinue care at the clinic within the next 3 months Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Retaining Study Participants Through the 3 Month Trial | 3 months | Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | baseline and 3 months | Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit. |
| Change From Baseline in HbA1c at 3 Months | baseline and 3 months | Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months. |
| Change From Baseline in Self-reported Medication Adherence at 3 Months | Baseline and 3 months | Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Attention Control Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes | 21 |
| Tailored Adherence Intervention Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers
Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Tailored Adherence Intervention | Attention Control | Total |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 10.7 | 54.5 years STANDARD_DEVIATION 11.3 | 57.6 years STANDARD_DEVIATION 11.1 |
| Annual income less than $40,000 | 19 Participants | 17 Participants | 36 Participants |
| Educational Status High School Degree | 13 Participants | 10 Participants | 23 Participants |
| Educational Status Less than High School | 2 Participants | 3 Participants | 5 Participants |
| Educational Status Some College and above | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 20 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
| Unemployed | 20 Participants | 9 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Feasibility of Retaining Study Participants Through the 3 Month Trial
Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.
Time frame: 3 months
Population: The number of participants that were retained in the study from baseline to 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Attention Control | Feasibility of Retaining Study Participants Through the 3 Month Trial | 20 Participants |
| Tailored Adherence Intervention | Feasibility of Retaining Study Participants Through the 3 Month Trial | 21 Participants |
Secondary
Change From Baseline in HbA1c at 3 Months
Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months.
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Change From Baseline in HbA1c at 3 Months | 0.6 percentage of A1c | Standard Error 0.49 |
| Tailored Adherence Intervention | Change From Baseline in HbA1c at 3 Months | -0.5 percentage of A1c | Standard Error 0.3 |
Secondary
Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months
Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit.
Time frame: baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Systolic blood pressure | -6.1 mmHg | Standard Error 3.9 |
| Attention Control | Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Diastolic blood pressure | -1.9 mmHg | Standard Error 2.3 |
| Tailored Adherence Intervention | Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Systolic blood pressure | -7.2 mmHg | Standard Error 3.7 |
| Tailored Adherence Intervention | Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Diastolic blood pressure | -3.5 mmHg | Standard Error 2 |
Secondary
Change From Baseline in Self-reported Medication Adherence at 3 Months
Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence.
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Change From Baseline in Self-reported Medication Adherence at 3 Months | 1.8 score on a scale | Standard Error 0.49 |
| Tailored Adherence Intervention | Change From Baseline in Self-reported Medication Adherence at 3 Months | 1.3 score on a scale | Standard Error 0.48 |